Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-01 @ 3:51 AM
Study NCT ID:
NCT03045250
Status:
WITHDRAWN
Last Update Posted:
2018-09-04
First Post:
2017-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Sponsor:
Albert Einstein College of Medicine
Organization:
Study Overview
Official Title:
Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCM
Brief Summary:
Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.
Detailed Description:
Rationale: Poorly controlled diabetes mellitus is associated with microvascular complications, which includes peripheral neuropathy. Peripheral neuropathy associated with diabetes is a painful condition. Its diagnosis is hampered by painful and long nerve conduction studies which fail to diagnose small nerve neuropathy. It is important to study methods of noninvasive methods of early detection, which are sensitive and specific in diagnosing early neuropathy and we propose a novel study that this can be detected in the cornea of the eye.
Aims:
* Estimate corneal small nerve fiber damage in young T1DM subjects (corneal fiber density, nerve branch density, and fiber length) and compare the results to healthy controls using corneal confocal microscopy (CCM).
* Estimate corneal nerve fiber damage in subjects with diabetes, with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsies and nerve conduction studies
* Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes.
* As a secondary outcome measure, to compare serum biomarkers including leptin, TNF alpha, and fibrinogen in patients with diabetes in those with neuropathy Vs. without neuropathy.
Aims:
* Estimate corneal small nerve fiber damage in young T1DM subjects (corneal fiber density, nerve branch density, and fiber length) and compare the results to healthy controls using corneal confocal microscopy (CCM).
* Estimate corneal nerve fiber damage in subjects with diabetes, with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsies and nerve conduction studies
* Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes.
* As a secondary outcome measure, to compare serum biomarkers including leptin, TNF alpha, and fibrinogen in patients with diabetes in those with neuropathy Vs. without neuropathy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: